GingivitisNCT02187016

Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

A study testing AirFloss + BreathRx, AirFloss + Listerine and Dental Floss in people with Gingivitis, run by Philips Oral Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Gingivitis
What is being tested?: AirFloss + BreathRx, AirFloss + Listerine and Dental Floss
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be willing and physically able to carry out all study procedures and be available at all times required for participation
Be able to fully understand and comply with the written and verbal instructions provided
Provide written Informed Consent
Be age 18 - 65 years
Agree to return study materials at the required visits
Be a non-smoker

Show all 11Show fewer

Have a minimum of 20 'scorable' teeth (excluding 3rd molars)
Have a minimum average plaque score of > 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation
Have a Gingival Bleeding Index of ->1 on at least 10 sites
Be a regular manual toothbrush user
Be a non or irregular flosser defined as using dental floss or any other interproximal cleaning technique once per week or less often

Who cannot join

A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion
Pregnant or nursing per subject report
A medical condition requiring antibiotic pre-medication prior to dental appointments
Diagnosis of xerostomia
Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth
Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion

Show all 24Show fewer

Oral surgery within the last 2 months
Current use of professionally dispensed bleaching products
A known allergy or sensitivity to products planned for use in this study
Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study
Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study
Participation in an oral care study within the previous 90 days
Be an employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm
Are a dental student or dental professional
A cardiac pacemaker or implanted cardiac defibrillator
Insulin-Dependent Diabetes
Current use of antibiotic medications or use within 4 weeks of enrollment
Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily)
Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion
Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion
Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion
Have a professional prophylaxis within 4 weeks of the study
Be a regular power toothbrush user

Trial locations and contacts

1 site in 1 country.

United States1 site

Silverstone Research Group
Las Vegas, Nevada, 89146

Other trials in United States

About this study

Official title: A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use

The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.

Conditions: Gingivitis
Being tested: AirFloss + BreathRx, AirFloss + Listerine, Dental Floss, Manual Toothbrush
Keywords: Gingivitis, plaque, interproximal cleaning, dental floss
Medical subject headings: Gingivitis, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AirFloss + BreathRxDevice
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
AirFloss + ListerineDevice
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Dental FlossDevice
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
Manual ToothbrushDevice
Manual Toothbrush used twice daily, 1 minute.

Study groups in NCT02187016
Study group	Role	What they receive
AirFloss + BreathRx	Experimental	Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day. Receives: Device: AirFloss + BreathRx
AirFloss + Listerine	Experimental	Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day. Receives: Device: AirFloss + Listerine
Dental Floss	Experimental	Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day. Receives: Device: Dental Floss
Manual Toothbrush	Active comparator	Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute Receives: Device: Manual Toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Measured: 14 days

Secondary outcomes (5)

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Measured: 28 days
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Measured: 14 days
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Measured: 28 days
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Measured: 14 days
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jul 2014

First posted10 Jul 2014 (estimated)
Study startJun 2014
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GingivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02187016
Sponsor's protocol ID: MAH-13-0151
Status last verified: Feb 2016
First submitted: 1 Jul 2014
Last updated: 8 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

All Gingivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use
ClinicalTrials.gov ID: NCT02187016
Acronym / sponsor ID: MAH-13-0151
Conditions: Gingivitis
Keywords: Gingivitis, plaque, interproximal cleaning, dental floss
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Philips Oral HealthcareIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 29 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AirFloss + BreathRx	Experimental	Device: AirFloss + BreathRxDevice: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day.
AirFloss + Listerine	Experimental	Device: AirFloss + ListerineDevice: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day.
Dental Floss	Experimental	Device: Dental FlossDevice: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.
Manual Toothbrush	Active comparator	Device: Manual ToothbrushDevice: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Be willing and physically able to carry out all study procedures and be available at all times required for participation
Be able to fully understand and comply with the written and verbal instructions provided
Provide written Informed Consent
Be age 18 - 65 years
Agree to return study materials at the required visits

Key exclusion criteria (24 listed)

A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion
Pregnant or nursing per subject report
A medical condition requiring antibiotic pre-medication prior to dental appointments
Diagnosis of xerostomia
Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AirFloss + BreathRxManual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.	Device	AirFloss + BreathRx
AirFloss + ListerineManual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.	Device	AirFloss + Listerine
Dental FlossManual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.	Device	Dental Floss
Manual ToothbrushManual Toothbrush used twice daily, 1 minute.	Device	Manual Toothbrush

Primary outcome

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
Time frame: 14 days
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).

5 secondary outcomes

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
Time frame: 28 days
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
Time frame: 14 days
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
Time frame: 28 days
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
Time frame: 14 days
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
Time frame: 28 days

Results and safety

Results posted to the registry on 29 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AirFloss + Rinse1	80	79
AirFloss + Rinse2	80	78
String Floss	79	78
Manual Toothbrush	51	51

Primary outcome: Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14

Time frame: 14 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	AirFloss + Rinse1 n = 79	AirFloss + Rinse2 n = 78	String Floss n = 79	Manual Toothbrush n = 51
Value	0.10 (0.01)	0.10 (0.01)	0.10 (0.01)	0.01 (0.01)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Oral changes from baseline evaluated at Day 14 and 28. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AirFloss + Rinse1	0 of 79 (0%)	2 of 79 (2.5%)	Not reported
AirFloss + Rinse2	0 of 78 (0%)	1 of 78 (1.3%)	Not reported
String Floss	0 of 78 (0%)	1 of 78 (1.3%)	Not reported
Manual Toothbrush	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Gingivitis

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pejmon Amini, DDS principal investigator

Silverston Research Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AirFloss + BreathRx, AirFloss + Listerine and Dental Floss in people with Gingivitis, run by Philips Oral Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.